Predictive Biomarker of Pre-Diabetes and Type II Diabetes (D003)

Tuesday, 25 October 2016

Researchers from the Biomedical Sciences Research Institute at Ulster University have discovered a novel biomarker for predicting early on-set on diabetes in the form of glycated insulin.

Problem Being Solved

Diabetes is a metabolic disorder estimated to affect greater than 180 million people worldwide according to the WHO with projections likely to more than double by the year 2030. Type II diabetes is often asymptomatic and its diagnosis is only around 50% with many patients often remaining undiagnosed for several years, especially in the first few years of onset (pre-diabetes). This delay in diagnosis increases the likelihood for diabetic complications.

Pre-diabetes is a major public health challenge in both developed and developing countries. The National Diabetes Association estimate that 16% of adults between 40-74 years in the U.S. have pre-diabetes and it is predicted that those individuals will develop type II diabetes within 10 years.

With no biomarker currently available to detect pre-diabetes and current methods of monitoring the disease using blood glucose or glycated haemoglobin being far from being ideal, there is clearly a need for the development of novel diagnostic technologies which are able to predict persons at risk of developing diabetes.


We have developed an optimized, specific immunoassay which quantifies naturally occurring glycated insulin found to be elevated in newly diagnosed diabetics as well as those patients predisposed to developing the disease. This novel marker has also been validated in a variety of preclinical studies including a diabetic ob/ob mouse model, where we have consistently shown that glycated insulin concentrations are increased at 6 weeks prior to the onset of hyperglycaemia at 9 weeks of age.


  • Can be used for the early diagnosis of diabetes (those predisposed to diabetes) and gestational diabetes.
  • Commercially significant as glycated haemoglobin (HbA1c) is currently the only test available for monitoring diabetes and has a number of well documented limitations.
  • HbA1c depends on the mean glucose level over 120 days while secretion of glycated insulin is a dynamic process; HbA1c cannot be used for identifying the onset of the disease which is vital for early intervention and lifestyle adjustments.
  • Potential for use in rapid point of care testing.

Opportunity/Partnership Sought

 An exclusive licensing of Ulster’s D003 patent portfolio provides an opportunity to enhance a licensor’s existing intellectual property pipeline or competitive positioning in this emerging field. In addition, the inventors of this technology are able to provide valuable know-how in order to assist in its successful commercialisation.

For more information please contact:

Dr Oonagh Lynch

Technology Commercialisation Executive

Research & Impact

Tel: +44 (0) 28 9036 6707

Mob: +44 (0) 77 6536 3191